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NOT YET RECRUITING
NCT07907640

Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients

Sponsor: Sunway University

View on ClinicalTrials.gov

Summary

This multicentre, prospective, single-arm cohort study will evaluate the real-world effectiveness and safety of Savagen, an NPRA-approved generic sacubitril/valsartan, in Malaysian adults aged 18 to 70 years with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%, NYHA class II-III). Approximately 80 patients initiating Savagen as part of routine clinical care at hospitals offering a Heart Failure Medication Therapy Adherence Clinic (HFMTAC) will be followed for 12 months. The primary outcome is the change in NT-proBNP from baseline to 12 months. Secondary outcomes include changes in LVEF, renal function (serum creatinine, eGFR), serum potassium, patient-reported health status (KCCQ) and dietary diversity (Dietary Diversity Score), a composite of cardiovascular death or first heart failure hospitalisation, and adverse events, including hypotension, hyperkalaemia, renal impairment and angioedema. The study does not aim to establish equivalence with the reference product; it will generate local real-world evidence on the effectiveness, tolerability, safety and patient-reported outcomes of generic sacubitril/valsartan in routine Malaysian HFrEF care.

Official title: Real-world Effectiveness and Safety of Savagen in Malaysian Patients With HFrEF: A Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-10-01

Completion Date

2028-09-30

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Savagen (sacubitril/valsartan)

Generic sacubitril/valsartan initiated and titrated by the treating physician according to standard institutional protocol and clinical guidelines. The study protocol does not prescribe a dose.

Locations (2)

Hospital Sultan Idris Shah Serdang

Kajang, Selangor, Malaysia

Hospital Shah Alam

Shah Alam, Selangor, Malaysia